By name: "KSB-D15-K0010" description: "Internet of Things and Digital Therapeutics: Understanding of emerging data sources including wearable device data, mobile health applications, d..." version: "1.0.0" domain: "D15" domain_name: "Sources of Information" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain internet of things and digital therapeutics" - "what is internet of things and digital therapeutics" - "explain internet of things and digital therapeutics" epa_mapping: "EPA-02, EPA-04" cpa_mapping: "CPA-05, CPA-07" regulatory_refs: "ICH-E2D Sec 3.2, MULTI-LIT-001"
KSB-D15-K0010: Internet of Things and Digital Therapeutics
Overview
Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
Understanding of emerging data sources including wearable device data, mobile health applications, digital therapeutics platforms, and connected medical devices that provide continuous safety monitoring capabilities and novel safety signal detection opportunities.
Context
- Major Section: Core Knowledge
- Section: Emerging Digital Information Sources
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
CPA Pathway
- CPA-05, CPA-07
Regulatory References
- ICH-E2D Sec 3.2
- MULTI-LIT-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in internet of things and digital therapeutics
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
- Connect to related EPAs: EPA-02, EPA-04
Key Competencies
- Understanding of emerging data sources including wearable device data, mobile health applications, digital therapeutics platforms, and connected medical devices that provide continuous safety monitoring capabilities and novel safety signal detection opportunities.
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D15 skills in Emerging Digital Information Sources
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31